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Heart FailureNCT06747689

Association Between Sleep Quality and Self-Care in Heart Failure Patients

An observational study of Heart Failure and Sleep Quality, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The research will be conducted as a prospective and relational study to longitudinally investigate the effect of sleep quality on self-care in patients with heart failure (HF) and to evaluate the relationship between self-care, sleep quality, and cognitive functions. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure, Sleep Quality, Self Care
How many people
207 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Nov 2026to 1 Dec 2027
How long will I take part?
6 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants will be recruited from the cardiology clinic of Dokuz Eylül University Hospital.

Who may be able to join

None listed.

Who cannot join

  • The study will exclude patients who:
  • Have been hospitalized within one month prior to inclusion,
  • Have experienced major psychological trauma or stress in the last three months,
  • Have serious comorbidities or malignant cancers,
  • Have advanced hearing impairment,
  • Are using prescription drugs for insomnia or psychiatric conditions,
  • Work night shifts, or
  • Reside in nursing homes.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Arzu AKBABA contact

05373925654

arzu.akbaba@deu.edu.tr

Turkey (Türkiye)1 site, 1 recruiting

  • Dokuz Eylul University Hospital

    Izmir

    Arzu AKBABA, +902324124797, arzu.akbaba@deu.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Effect of Sleep Quality on Self-Care in Patients With Heart Failure: A Longitudinal Analysis

The research will be conducted as a prospective and relational study to longitudinally investigate the effect of sleep quality on self-care in patients with heart failure (HF) and to evaluate the relationship between self-care, sleep quality, and cognitive functions. The sample size was calculated using the multiple linear regression model with the G*Power Version 3.1 program. Based on a medium effect size of 0.15, an alpha of 0.05, a power of 0.95, and 18 predictors, the sample size was determined to be 188. Considering a potential dropout rate of 10%, it was decided to complete the study with a minimum of 207 participants.

Data will be collected from patients who apply to the Dokuz Eylül University Cardiology Outpatient Clinic and meet the inclusion criteria. After signing the informed consent form, participants will be followed up at baseline, the 1st month, the 3rd month, and the 6th month by telephone. The Statistical Package for Social Sciences (SPSS) 24.0 will be used to analyze the numerical data of the research. Descriptive statistics, including number, percentage, mean, and standard deviation, as well as inferential statistics such as the χ2 test, t-test for independent groups, and multiple linear regression, will be employed in the data analysis.

Medical subject headings
Heart Failure, Sleep Initiation and Maintenance Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sleep quality

    The Pittsburgh Sleep Quality Index (PSQI) was developed by Buysse and colleagues in 1989. It is a scale that provides a quantitative measurement of sleep quality, distinguishing between good and poor sleep. Its validity and reliability study was conducted in Turkey in 1996 by Agargün and colleagues, with a Cronbach's alpha value of.80. The scale is a four-point Likert type and contains a total of 24 questions, comprising seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping pills, and daytime dysfunction. Each component is scored between 0 and 3 based on the frequency of symptoms. The sum of the seven component scores yields the total PSQI score, which ranges from 0 to 21. A total score of 5 or above indicates poor sleep quality and a high level of sleep disturbance.

    Measured: From December 2024 to January 2026

  2. Self Care

    Self-care will be assessed using the nine-item version of the European Heart Failure Self-Care Behavior Scale (Jaarsma et al., 2003). The validity and reliability of the scale in our country were established by Yıldız and Erci (Yıldız \& Erci, 2018). This Likert-type scale measures self-care behaviors such as recognizing symptoms like edema, dyspnea, and fatigue related to HF, adhering to regular medication use, monitoring weight, and restricting fluid and salt intake. Participants are asked to choose one of the following options for each item: completely agree (1), agree (2), undecided (3), disagree (4), or completely disagree (5). A higher total score indicates lower self-care, while a lower score indicates higher self-care. Fit measures for the Structural Equation Model of the scale include RMSEA = 0.047 (CI = 0.00-0.079), AGFI = 0.83, and GFI = 0.91 (Jaarsma et al., 2003). In the study by Yıldız and Erci, the Cronbach's alpha coefficient was reported as 0.82 (Yıldız \& Erci,2018)

    Measured: From December 2024 to January 2026

Secondary outcomes (1)

  1. Cognitive Fuction

    The Telephone Cognitive Screening Test (T-KogS) was adapted from the ALFI-Mini Mental Assessment test by Newkirk and colleagues. This scale can be administered face-to-face to assess the cognitive functions of Alzheimer's patients or used in situations where face-to-face interviews are not possible (Newkirk et al., 2004). The T-KogS evaluates cognitive domains including orientation (e.g., year, season, day, day of the week, month, state, county, city/town, address, and telephone number), registration and recall (e.g., recalling three objects: apple, table, penny), attention (e.g., writing the word "WORLD" backwards), and language (e.g., repetition of "no if, and, or but," single object naming, and a three-step command). The total score on the T-KogS ranges from 0 to 26, with higher scores indicating better cognitive performance. The Turkish validity and reliability study of the scale was conducted by Naharci et al. in 2020, and the Cronbach's alpha value was reported as 0.73.

    Measured: From December 2024 to January 2026

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2024
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion1 May 2027 (estimated)
  4. Study completion1 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
207 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06747689
Sponsor's protocol ID
2024/41-11
Status last verified
Oct 2026
First submitted
18 Dec 2024
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure and Sleep Quality, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Arzu AKBABA (05373925654, arzu.akbaba@deu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sleep quality (time frame: From December 2024 to January 2026). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06747689.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.

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